NCT03550820

Brief Summary

We aim to examine energy metabolism in patients with pulmonary MAC and clarify the causes of emaciation. We will also investigate the following: the relation between energy metabolism and degree of pulmonary MAC progression; relations among hospitalization, mortality rate, and time-course of changes in energy metabolism; and factors that affect energy metabolism.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2018

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

May 26, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 8, 2018

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 27, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2021

Completed
Last Updated

December 28, 2021

Status Verified

December 1, 2021

Enrollment Period

3.7 years

First QC Date

May 26, 2018

Last Update Submit

December 26, 2021

Conditions

Pulmonary MACEnergy MetabolismEmaciation

Keywords

pulmonary MACenergy metabolism

Outcome Measures

Primary Outcomes (1)

  • Relation between energy balance and pulmonary MAC severity

    Three years

Secondary Outcomes (4)

  • Relation between inflammation (CRP et.) and pulmonary MAC severity

    Three years

  • Relation between bone mineral density and pulmonary MAC severity

    Three years

  • Relation between hormone secretion and pulmonary MAC severity

    Three years

  • Relation between pulmonary function and pulmonary MAC severity

    Three years

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Petients with pulmonary MAC

You may qualify if:

  • Subjects with pulmonary MAC.

You may not qualify if:

  • Subjects with severe cardiovascular disease, diabetes, neurological disease, renal failure, endocrine disease and malignant neoplasm.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Hospital Organization Minami Kyoto Hospital

Jōyō, Kyoto, 610-0113, Japan

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples (serum, plasma)

MeSH Terms

Conditions

Emaciation

Condition Hierarchy (Ancestors)

ThinnessBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2018

First Posted

June 8, 2018

Study Start

May 1, 2018

Primary Completion

December 27, 2021

Study Completion

December 27, 2021

Last Updated

December 28, 2021

Record last verified: 2021-12

Locations

JP(1)